A randomized-controlled feasibility study of internet-based cognitive behavioral therapy and mindfulness-based therapy for hypoactive sexual desire dysfunction in women with comorbid depression

性欲减退（HSDD）是女性中最常见的性功能障碍之一，其特征是临床上明显的性欲减少或缺乏。虽然HSDD每年影响约7%的德国女性，但其在临床人群中的患病率，尤其是在患有抑郁症的女性中，要高得多。虽然有相当多的证据表明认知行为疗法（CBT）和正念疗法（MBT）都是治疗HSDD的有效方法，但大多数女性没有接受治疗。这种对HSDD治疗不足的情况在患有抑郁症的女性身上更为明显，她们通常被排除在HSDD的研究试验之外，她们的性问题经常被她们的精神卫生保健提供者所忽视。造成这种情况的原因之一是，精神卫生保健提供者（例如精神科医生）认为性问题的治疗是次要的，不觉得自己有资格提供治疗，或者（通常是错误的）假设，一旦伴随的精神障碍得到缓解，HSDD就会自动改善。本提案旨在通过开发两个基于互联网的项目，遵循CBT或MBT方法（即iCBT和iMBT），使用以患者为中心的迭代治疗开发过程，然后提供广泛的可行性数据，为更大规模的确认性试验提供信息，从而缩小这一研究和治疗差距。在该建议的第一阶段，将进行两项焦点小组研究，以收集有关目标人群治疗偏好的全面信息，以产生关于哪些内容和治疗练习可能最相关的想法，并根据干预措施的原型获得关于关键治疗组成部分（例如，病例小品）的详细反馈。作为这一过程的一部分，参与者将学习iCBT和iMBT干预措施的内容，同时用语言表达他们的想法，并就经验提供详细的反馈。在第二阶段，即主要的可行性研究中，总共80名妇女将被随机分配到iCBT或iMBT。在纳入后6周和12周进行定量和定性数据评估。在此阶段，将评估可行性数据（即招募和依从性的可行性，治疗满意度，安全性和风险，以及初步治疗效果）。第二阶段的数据将根据红绿灯系统（即红色：“不进行”，黄色：“修改和改进”，绿色：“进行更大规模的试验”）进行评估，以确定进行更大规模验证性试验的可行性和时间尺度。这一建议是为患有共病精神障碍的妇女提供基于证据的性问题心理护理的关键一步，这些妇女的性问题非常普遍，但在临床实践中仍未得到充分研究和服务。

Hypoactive sexual desire dysfunction (HSDD), characterized by a clinically significant reduction or absence of sexual desire, is one of the most common sexual dysfunctions among women. While HSDD affects about 7% of women in Germany annually, its prevalence in clinical populations, especially among women with depressive disorders, is much higher. While there is considerable evidence that cognitive behavioral therapy (CBT) and mindfulness-based therapy (MBT) are both effective treatments for HSDD, most women do not receive treatment. This undertreatment of HSDD is even more pronounced in women with depression who are usually excluded from research trials on HSDD and whose sexual concerns are frequently ignored by their mental health care providers. Among the reasons for this are that mental health care providers (e.g., psychiatrists) consider treatment of sexual problems to be of secondary importance, do not feel qualified to provide treatment, or have the (often false) assumption that HSDD will automatically improve once the comorbid mental disorder is remitted. This proposal aims to close this research and treatment gap by developing two internet-based programs following either a CBT or MBT approach (i.e., iCBT and iMBT), using a patient-centered iterative treatment development process, and then providing extensive feasibility data to inform a larger-scale confirmative trial. In Phase 1 of this proposal, two focus-group studies will be conducted to gather comprehensive information on the treatment preferences of the target population, to generate ideas about what content and therapeutic exercises could be most relevant, and to obtain detailed feedback on key treatment components (e.g., case vignettes) based on prototypes of the interventions. As part of this process, participants will work through the content of the iCBT and iMBT interventions while verbalizing their thoughts and providing detailed feedback on the experience. In Phase 2, the main feasibility study, a total of 80 women will be randomized to either iCBT or iMBT. Both quantitative and qualitative data assessments will be conducted at six and twelve weeks after inclusion. In this phase, feasibility data (i.e., the feasibility of recruitment and adherence, treatment satisfaction, safety and risks, as well as preliminary treatment efficacy) will be assessed. Data of Phase 2 will be evaluated based on a traffic-light system (i.e., red: “do not proceed”, yellow: “revise and improve, green: “proceed to larger trial”) to determine the feasibility and time-scale of a larger-scale confirmatory trial. This proposal is a crucial step in providing evidence-based psychological care for sexual concerns to women with comorbid mental disorders, a population whose highly prevalent sexual problems remain under-researched as well as under-served in clinical practice.